Thursday, April 01, 1999
Hepatitis B vaccine under microscope
Pros, cons of Ohio's move to require children to get protection
BY SUE MacDONALD
The Cincinnati Enquirer
On this specific topic, Evonne Herkert and Dr. William Balistreri agree: Every parent should know the risks and benefits of vaccines before they allow their newborns to be immunized. After that, things get fuzzy and a little controversial.
Ms. Herkert, of Goshen, has declined all vaccines for her 3-year-old daughter, Kelly. The hepatitis B vaccine is particularly worrisome to Ms. Herkert and her husband because of reported neurological side effects in children — the same problems that led French health officials to remove it from their required vaccine list in October.
“As a parent, I feel a strong responsibility to research immunological options for my child's health and well being,” says Ms. Herkert, a medical massage therapist and owner of the Right Touch Therapeutic Center in O'Bryonville.
But Dr. Balistreri, liver specialist at Children's Hospital, says the hepatitis B shot is the equivalent of a vaccine against liver cancer — a serious cancer that's increasing. And although every vaccine carries risk, he says, this one's pretty safe and already administered worldwide to 500 million people.
“If we had an HIV vaccine or a breast cancer vaccine, the line would stretch from here to Cleveland,” he says.
Hearings in Columbus
The vaccination question has come to a head in Ohio, where on April 15 state legislators on the House Health, Retirement and Aging Committee will continue the debate on the new policy to require the hepatitis B vaccine for all Ohio children entering kindergarten or first grade this fall.
Earlier this week, Ohio Rep. Dale Van Vyven, R-Sharonville, the committee chairman, said that the state's vaccine requirement was tacked onto a 1998 solid waste bill — without public hearings — after he had consulted with a lobbyist for Smith-Kline Beecham, a drug company that makes the vaccine. Hearings this month in Columbus will allow input from the public.
Hepatitis B is a liver disease that spreads from one person to another through infected blood from shared intravenous drug needles and upprotected sex, from infected mother to newborn or within households where one person is infected.
Here's a look at the pros and cons of the hepatitis B vaccine:
Pro-vaccine arguments
Dr. Balistreri is a liver specialist at Children's Hospital Medical Center (CHMC) who sees the devastation caused by hepatitis B, a leading cause of liver cancer and a chronic liver disease that infects an estimated 200,000 Americans and kills about 5,000 of them a year.
Dr. Balistreri agrees with many other public health officials that the only way to prevent hepatitis-B, a primarily adult disease that can cause cirrhosis and scarring of the liver, is to immunize children universally at birth. Vaccine programs rely on compliance in order to be effective.
Adds Dr. Sheldon Polosnky, pediatrician at Group Health Associates: “We're giving hepatitis B vaccine to children, but we're not trying to prevent hepatitis B in children. We're trying to prevent it in adults. ... I've not seen a single serious side effect in any child that I'm aware of.”
Widely endorsed
The vaccine has been endorsed by nearly every major public health group, including the World Health Organization, U.S. Centers for Disease Control and Prevention and American Academy of Pediatrics. (Also by Hepatitis Foundation International, a non-profit New Jersey group funded by two major drug companies).
The fact that the vaccine has been given to more than 500 million people worldwide since 1982 attests to its overall safety, Dr. Balistreri says.
“If we can start to eliminate (hepatitis B) now,” he says, “the incidence in 2015 will be zero.”
The numbers, however, need clarification. According to government estimates, 200,000 or more Americans are infected each year, but that number is based on estimates of its prevalence in the population. In 1997, the CDC recorded 10,416 cases of hepatitis B nationwide, 110 of them in children under 4. These were cases with symptoms serious enough to require doctor's visits and notification of local health departments.
For each person whose hepatitis is reported, another 19-20 might be infected without symptoms, becoming carriers able to pass the disease to others, including children, notes Dr. Eric Mast, head of hepatitis surveillance for the U.S. Centers for Disease Control & Prevention in Atlanta.
Dr. Balistreri urges all doctors to listen to legitimate parental concerns about the vaccine, give parents sound medical information and allow them to make up their minds based on facts, not hearsay. Most parents, he says, agree to the vaccine.
Opponents worry about the safety of the hepatitis-B vaccine and question the wisdom of vaccinating infants and children for what is primarily an adult disease, especially one spread through risky behaviors.
“Many people try to portray us as anti-vaccine,” says Kathi Williams, director of the National Vaccine Information Center (NVIC) in Vienna, Va. “We're not. But we really are questioning the policy of vaccinating healthy 12-hour-old babies who are not at risk for this disease.”
What's worse? they ask. A disease that infected 279 children under 14 in 1996, or a vaccine that caused 214 negative reactions and 13 deaths in children under 14 in the same year?
They base their concerns on the Vaccine Adverse Event Reporting System (VAERS), a federal agency to which doctors report negative reactions to vaccines among their patients. Reactions most commonly linked to hepatitis-B in adults and children are arthritis, multiple sclerosis-like damage to nerves, chronic fatigue, diabetes, rashes, joint pain, seizures and immune disorders.
Testing questioned
Critics also are concerned because the original vaccine, derived from human hepatitis-B blood products, was updated in 1986 to a genetically engineered recombinant DNA vaccine — one that NVIC parents say wasn't tested long enough or on enough children to establish long-term safety and effectiveness.
“The deciding factors for me were that the vaccine is by no means a guarantee,” says Ms. Herkert, who prefers holistic approaches — including whole, unprocessed foods and homeopathic remedies — to bolster her daughter's immune system.
Parents also say they want more options and freedom of choice, not more vaccine mandates. Because children sometimes receive vaccines for three or more diseases in one visit, it's never possible to prove which parts of the vaccine (if any) cause negative reactions — a fact used by drug companies to silence their critics and promote their products.
“One of the reasons we're so concerned is that this is the vaccine technology of the future, and we need to make sure it's as safe as it can possibly be,” the NVIC's Ms. Williams says. “One of the things that we run into all the time is denial that the vaccines can cause problems, and unfortunately, our policies in this country have preceded our science. There's very little science in this vaccine.”
Next steps in debate
The hearings in Columbus are expected to raise similar issues about effectiveness, safety and parental choice. Ohio allows parents to object to mandatory vaccines on religious, philosophical and medical grounds. Kentucky and Indiana allow religious objections.
Some parents just want options, including waiting until their children are teens to get the vaccination. Critics have suggested vaccinating only adults at risk for hepatitis B, although health officials say it's nearly impossible to follow through and make sure adults get all three shots in the vaccine series.
Dr. Balistreri agrees no parent should be in the dark about hepatitis B or the vaccine, and doctors and pediatricians need to take parents' concerns seriously.
“Health-care providers, whether we're prescribing aspirin or a vaccine, need to present the risks and benefits to parents,” he says. “Most parents will defer to you, but I think it's foolhardy to ignore their concerns. Having been both a physician and a patient, I want people to explain things to me about risks and benefits.
“I can't sit here and say, "Don't worry, there's no risk,' ” he explains. “That would be stupid. It's equally stupid to stop this vaccine program because of what I call the "chicken little' phenomenon, with people claiming the sky is falling. The sky is not falling.”
PUBLIC HEARINGS
For information on state hearings on the policy to require the hepatitis B vaccine for all Ohio children, contact the office of state Rep. Dale Van Vyven, chairman of the House Health, Retirement and Aging Committee: (614) 466-8120.
headHEPATITIS B SYMPTOMS
Hepatitis B is caused by a virus that passes from one person to another through infected blood and body fluids. It most typically spreads by sharing infected drug needles, sexual contact with an infected person or contact with an infected person's blood. Infected mothers also can pass it to newborns.
Symptoms include darkened urine, fatigue, fever, hives/rash, joint pain, poor appetite, vomiting, and jaundice (yellowed skin and whites of the eyes).
About 90 percent of people who get hepatitis B recover and then are immune to the disease. About 5,000 Americans die each year from it. Hepatitis-B is a complicating factor that can lead to liver cancer, cirrhosis and chronic liver damage.
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